CN100566721C - Clindamycin palmitate hydrochloride chewing tablet andi and preparation method thereof - Google Patents
Clindamycin palmitate hydrochloride chewing tablet andi and preparation method thereof Download PDFInfo
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- CN100566721C CN100566721C CNB2005101298574A CN200510129857A CN100566721C CN 100566721 C CN100566721 C CN 100566721C CN B2005101298574 A CNB2005101298574 A CN B2005101298574A CN 200510129857 A CN200510129857 A CN 200510129857A CN 100566721 C CN100566721 C CN 100566721C
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- clindamycin
- palmitate
- hydrochloride
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Abstract
The invention discloses a kind of clindamycin palmitate hydrochloride chewing tablet andi and preparation method thereof.The advantage of this product be have the suitability for industrialized production of being easy to, technology is easy, adopts dry granulation, the activity of having preserved clindamycin hydrochloride palmitate to greatest extent; Be convenient to patient and take, chew, suck clothes or swallow, patient not water also can take, the inconvenient patient of conventional tablet that is specially adapted to swallow, and the present invention is fragrant and sweet good to eat after seasoning, is convenient to patient and uses, and compliance is good; It is single that it has solved Clindamycin Hydrochloride Palmic acid dosage form, listing at present only has the problem of granule, dispersible tablet, enriched doctor, patient's dosage form selection leeway.
Description
Technical field
The present invention relates to treat clindamycin palmitate hydrochloride chewing tablet andi of the kind infectious disease that causes by aerobic G+ bacterium and anaerobe and chlamydia, protozoon etc. and preparation method thereof.
Background technology
Clindamycin hydrochloride palmitate is a kind of antibacterials of being succeeded in developing by general strong (Upjohn) company, and commodity are called Cleocin Pediatric
External peroral dosage form mainly is a dry syrup.Domesticly develop this product granule in the nineties, earlier 1900s is developed this product tablet formulation.
Clindamycin palmitate hydrochloride chewing tablet andi is the prodrug of clindamycin, and oral back absorption rapidly also is hydrolyzed to reactive precursor in vivo and brings into play curative effect.Clindamycin hydrochloride palmitate has the unique chemical structure, is not subjected to the influence of beta-lactamase, and is still effective to the Resistant strain of part penicillin resistant, cephalosporin, erythromycin, tetracycline, and mechanism of action is synthetic for suppressing bacterioprotein.The clindamycin hydrochloride palmitate antibacterial action is strong, and aerobic G+ bacterium and anaerobe and chlamydia, protozoon are all had the strong antibiotic effect.Clindamycin hydrochloride palmitate excellent absorption and extensive tissue distribution characteristic, clinical pulmonary infection, bone joint infection, otorhinolaryngology infection, abdominal cavity infection, pelvic infection, protozoan infection and periodontal disease, the skin soft-tissue infection of being widely used in all has curative effect preferably.Clindamycin hydrochloride palmitate similar medicine has abroad recorded the pharmacopeia into American-European developed country, and good safety is arranged, and is particularly suitable to penicillin, cephalosporin patient hypersensitive.
Clindamycin hydrochloride palmitate is compared with clindamycin, indication is basic identical, modification by chemical constitution, clindamycin hydrochloride palmitate has not had the bitterness of clindamycin, and easier absorption, side effect is littler than Clindamycin Hydrochloride, and patient's better tolerance is so be suitable for child and gerontal patient's medication especially.At present, domestic only have the clindamycin hydrochloride palmitate granule that Xi-nan Synthetic Medicine Factory produces (trade name: but youngster gives birth to) and the clindamycin palmitate hydrochloride dispersion tablet of Chongqing Carelife Pharmaceutical Co., Ltd.'s production (trade name: Kai Laikelin) appear on the market, dosage form be single.In order to enrich the kind of clindamycin hydrochloride palmitate, make the patient that more dosage form selection leeway be arranged, this shows that the present invention will have vast market prospect.
Summary of the invention
In order to solve the single shortcoming of prior art clindamycin hydrochloride palmitate peroral dosage form; Improve its bioavailability; Make the patient that more dosage form selection leeway be arranged; The toxic and side effects that reduces medicine is the purpose that the present invention develops clindamycin palmitate hydrochloride chewing tablet andi.
Another object of the present invention provides the method for preparing clindamycin palmitate hydrochloride chewing tablet andi.
The object of the present invention is achieved like this: (a) clindamycin hydrochloride palmitate is crossed the 40-60 mesh sieve, and used adjuvant is crossed the 60-80 mesh sieve, and is standby; (b) take by weighing the clindamycin hydrochloride palmitate and the adjuvant of recipe quantity; (c) place blender to be mixed to evenly clindamycin hydrochloride palmitate, mannitol, Icing Sugar, solubilizing agent, correctives, Pulvis Talci etc., grind the squeezing and pressing method granulation, cross 10-40 mesh sieve granulate, must do granule with rolling; (d) add magnesium stearate and essence in the granule that (c) makes, behind the mix homogeneously, tabletting after airtight 0.5-3 hour makes chewable tablet.
Compared with prior art, the present invention has following advantage:
1, the present invention makes clindamycin hydrochloride palmitate stripping more fully owing to added as solubilizing agents such as poloxamer, PEG4000, makes that absorption of human body is fast, bioavailability is high;
2, be convenient to patient and take, chew, suck clothes or swallow, patient not water also can take, the inconvenient patient of conventional tablet that is specially adapted to swallow, and the present invention is fragrant and sweet good to eat after seasoning, is convenient to patient and uses, and compliance is good;
3, it to have solved peroral dosage form single, the problem of granule and dispersible tablet only arranged, enriched doctor, patient's dosage form selection leeway;
4, the method that is used in is granulated, and has preserved the activity of clindamycin hydrochloride palmitate to greatest extent, and be easy to suitability for industrialized production, technology is easy.
The invention will be further described below in conjunction with the specific embodiment.
The specific embodiment
To further illustrate the present invention in following examples, these embodiment only are used to the present invention is described and to the present invention without limits.
Embodiment 1:
1, the prescription of clindamycin palmitate hydrochloride chewing tablet andi is composed as follows: (37.5mg specification in 1000) wherein contains:
Clindamycin hydrochloride palmitate 37.5g (in clindamycin)
Mannitol 250g
Icing Sugar 50g
Poloxamer 10g
Steviosin 5g
Pulvis Talci 10g
Magnesium stearate 15g
Essence 20ml
2, the clindamycin palmitate hydrochloride chewing tablet andi preparation method is as follows:
(a) clindamycin hydrochloride palmitate is crossed the 40-60 mesh sieve, and used adjuvant is crossed the 60-80 mesh sieve, and is standby; (b) take by weighing the clindamycin hydrochloride palmitate and the adjuvant of recipe quantity; (c) place blender to be mixed to evenly clindamycin hydrochloride palmitate, mannitol, Icing Sugar, solubilizing agent, correctives, Pulvis Talci etc., grind the squeezing and pressing method granulation, cross 10-40 mesh sieve granulate, must do granule with rolling; (d) add magnesium stearate and essence in the granule that (c) makes, behind the mix homogeneously, tabletting after airtight 0.5-3 hour makes chewable tablet.
Sampling then, detection level and dissolution and hardness all meet relevant drug standard.
Embodiment 2:
1, the prescription of clindamycin palmitate hydrochloride chewing tablet andi is composed as follows: (75mg specification in 1000) wherein contains:
Clindamycin hydrochloride palmitate 75g (in clindamycin)
Mannitol 200g
Icing Sugar 40g
Poloxamer 15g
Steviosin 5g
Pulvis Talci 10g
Magnesium stearate 15g
Essence 25ml
2, clindamycin palmitate hydrochloride chewing tablet andi preparation method one, two is with embodiment 1.
Embodiment 3:
1, the prescription of clindamycin palmitate hydrochloride chewing tablet andi is composed as follows: (150mg specification in 1000) wherein contains:
Clindamycin hydrochloride palmitate 150g (in clindamycin)
Mannitol 160g
Icing Sugar 40g
Poloxamer 30g
Steviosin 6g
Pulvis Talci 10g
Magnesium stearate 15g
Essence 30ml
2, clindamycin palmitate hydrochloride chewing tablet andi preparation method one, two is with embodiment 1.
Embodiment 4:
1, the prescription of clindamycin palmitate hydrochloride chewing tablet andi is composed as follows: (300mg specification in 1000) wherein contains:
Clindamycin hydrochloride palmitate 300g (in clindamycin)
Mannitol 120g
Icing Sugar 30g
Poloxamer 35g
Steviosin 8g
Pulvis Talci 15g
Magnesium stearate 20g
Essence 40ml
2, clindamycin palmitate hydrochloride chewing tablet andi preparation method one, two is with embodiment 1.
Embodiment 5:
1, the prescription of clindamycin palmitate hydrochloride chewing tablet andi is composed as follows: (75mg specification in 1000) wherein contains:
Clindamycin hydrochloride palmitate 75g (in clindamycin)
Sorbitol 200g
Icing Sugar 40g
Poloxamer 15g
Steviosin 5g
Pulvis Talci 10g
Magnesium stearate 15g
Fructus Citri Limoniae essence 25ml
2, clindamycin palmitate hydrochloride chewing tablet andi preparation method one, two is with embodiment 1.
Embodiment 6:
1, the prescription of clindamycin palmitate hydrochloride chewing tablet andi is composed as follows: (75mg specification in 1000) wherein contains:
Clindamycin hydrochloride palmitate 75g (in clindamycin)
Sorbitol 200g
Icing Sugar 40g
Poloxamer 15g
Aspartame 5g
Pulvis Talci 10g
Magnesium stearate 15g
Orange flavor 25ml
2, clindamycin palmitate hydrochloride chewing tablet andi preparation method one, two is with embodiment 1.
Claims (2)
1, a kind of clindamycin palmitate hydrochloride chewing tablet andi is characterized in that: every clindamycin hydrochloride palmitate that contains the clindamycin that is equivalent to 30-350mg, and its prescription is composed as follows, in 1000, wherein contains:
Clindamycin hydrochloride palmitate is in clindamycin 30-350g
Mannitol 50-300g
Icing Sugar 30-100g
Solubilizing agent 10-50g
Correctives 5-20g
Pulvis Talci 10-30g
Magnesium stearate 10-30g
Essence 10-50ml
Described solubilizing agent is: poloxamer or PEG-4000; Described correctives is: steviosin or aspartame.
2, the preparation method of a kind of clindamycin palmitate hydrochloride chewing tablet andi as claimed in claim 1 is characterized in that, comprises the steps:
(a) clindamycin hydrochloride palmitate is crossed the 40-60 mesh sieve, and all adjuvants are crossed the 60-80 mesh sieve, and are standby;
(b) take by weighing the clindamycin hydrochloride palmitate and the adjuvant of recipe quantity;
(c) clindamycin hydrochloride palmitate, mannitol, Icing Sugar, solubilizing agent, correctives and Pulvis Talci are placed blender be mixed to evenly, grind the extruding dry granulation, cross 10-40 mesh sieve granulate, must do granule with rolling;
(d) make adding magnesium stearate and essence in the granule at (c), behind the mix homogeneously, seal tabletting after 0.5-3 hour, make chewable tablet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005101298574A CN100566721C (en) | 2005-12-09 | 2005-12-09 | Clindamycin palmitate hydrochloride chewing tablet andi and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005101298574A CN100566721C (en) | 2005-12-09 | 2005-12-09 | Clindamycin palmitate hydrochloride chewing tablet andi and preparation method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN1977856A CN1977856A (en) | 2007-06-13 |
| CN100566721C true CN100566721C (en) | 2009-12-09 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB2005101298574A Expired - Fee Related CN100566721C (en) | 2005-12-09 | 2005-12-09 | Clindamycin palmitate hydrochloride chewing tablet andi and preparation method thereof |
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Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2313083A1 (en) * | 2008-07-22 | 2011-04-27 | Lupin Limited | Oral compositions of clindamycin |
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2005
- 2005-12-09 CN CNB2005101298574A patent/CN100566721C/en not_active Expired - Fee Related
Non-Patent Citations (7)
| Title |
|---|
| 泊洛沙姆在药学上的应用. 林东海等.中国新药杂志，第4卷第1期. 1995 |
| 泊洛沙姆在药学上的应用. 林东海等.中国新药杂志，第4卷第1期. 1995 * |
| 聚乙二醇的生产和应用. 刘兆滨等.齐齐哈尔轻工学院学报，第11卷第4期. 1995 |
| 聚乙二醇的生产和应用. 刘兆滨等.齐齐哈尔轻工学院学报，第11卷第4期. 1995 * |
| 药剂学. 崔福德，第112页第27行，第113页第22行，第114页第31-32行,第119页第18-26行，第120页第1-11行，人民卫生出版社. 2004 药剂学. 张强，第170页第28行，第172页第4-7行，第25-30行，第173页第3行、第15行，第175页第19-23行，第29-33行，第178页第2行，北京大学医学出版社. 2005 |
| 药剂学. 崔福德，第112页第27行，第113页第22行，第114页第31-32行，第119页第18-26行，第120页第1-11行，人民卫生出版社. 2004 * |
| 药剂学. 张强，第170页第28行，第172页第4-7行，第25-30行，第173页第3行、第15行，第175页第19-23行，第29-33行，第178页第2行，北京大学医学出版社. 2005 * |
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| CN1977856A (en) | 2007-06-13 |
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